Histology

EQS-News: Immunic Highlights 2023 Accomplishments and Upcoming Milestones

Retrieved on: 
Friday, January 5, 2024
Janus, Biotechnology, Conference, MRI, Serum, Histology, Regeneration, PMS, Multiple sclerosis, Woman, Disease, Calcium, Clinical trial, Investment, AFL, SIRT6, Medicinal chemistry, Ulcerative colitis, Biomarker, Journal of Medicinal Chemistry, DHODH, Patient, Journal, RMS, Magnetic resonance imaging, Pharmaceutical industry

“With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.

Key Points: 
  • “With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.
  • A more thorough review of recent events and upcoming milestones follows:
    Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
  • Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Immunic Highlights 2023 Accomplishments and Upcoming Milestones

Retrieved on: 
Friday, January 5, 2024
Janus, Biotechnology, Conference, MRI, Serum, Histology, Regeneration, Entire, PMS, Multiple sclerosis, Woman, Disease, Sirtuin 6, Calcium, Clinical trial, Investment, AFL, SIRT6, Medicinal chemistry, Ulcerative colitis, Biomarker, Journal of Medicinal Chemistry, DHODH, Patient, Journal, RMS, Magnetic resonance imaging, Pharmaceutical industry

"With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.

Key Points: 
  • "With vidofludimus calcium (IMU-838) and IMU-856, we have two development programs beyond clinical proof-of-concept which is an outstanding achievement of our entire team.
  • A more thorough review of recent events and upcoming milestones follows:
    Announced a three-tranche private placement of up to $240 million with participation from select new and existing investors today.
  • Immunic believes that this data illustrates biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further reinforcing its neuroprotective potential.
  • Immunic believes this data provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

Sensei Biotherapeutics Provides Corporate Update and Highlights Key Upcoming Milestones

Retrieved on: 
Thursday, January 4, 2024
Biology, Sensei, Lung cancer, CD28, CRC, Neoplasm, Tumor microenvironment, Biotechnology, IND, DLT, FDA, VSIG4, CMO, Research, Colorectal cancer, MSS, Physician, Cancer, Pharmacokinetics, CD39, Head, Novartis, Exelixis, Part-time, Histology, VISTA, American College, Genentech, Internal medicine, Oncology, Patient, Safety, Therapy, NSCLC, Pharmaceutical industry

BOSTON, Jan. 04, 2024 (GLOBE NEWSWIRE) --  Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today provided corporate updates on its research and development programs and upcoming milestones.

Key Points: 
  • BOSTON, Jan. 04, 2024 (GLOBE NEWSWIRE) --  Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today provided corporate updates on its research and development programs and upcoming milestones.
  • In the monotherapy dose escalation arm, patients have cleared all planned dosing cohorts of 0.3, 1, 3, 10 and 15 mg/kg.
  • Anticipated milestones for the SNS-101 Phase 1/2 clinical trial include:
    Sensei announces that Ron Weitzman, M.D., F.A.C.P., has joined Sensei as part-time Chief Medical Officer.
  • As a result, Sensei will pause IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28).

Enspectra Health Announces US FDA Clearance of VIO‎™ System, First of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time

Retrieved on: 
Wednesday, January 3, 2024
Dermatology, US FDA, Physician, Histology, Epidermis, FDA, Blood, Trial of the century, Collagen, Marie Cassidy, Pathology, VIO, Algorithm, Skin, Medical imaging

MOUNTAIN VIEW, Calif., Jan. 3, 2024 /PRNewswire/ -- Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging.

Key Points: 
  • MOUNTAIN VIEW, Calif., Jan. 3, 2024 /PRNewswire/ -- Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging.
  • VIO, the first of its kind technology, combines reflectance confocal and multiphoton microscopy to enable cellular resolution, cross-sectional imaging of skin in seconds.
  • Easily portable and handheld, VIO digitizes pathology directly from a patient's skin to provide clinical insights for physicians.
  • This is the first multiphoton imaging modality to ever be cleared by the FDA," said Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health.

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, Platinum, Artery, INN, HER2, Histology, Hypertension, Cancer, Neoplasm, Anatomy, Paclitaxel, IIA, Diarrhea, Breast, Fatigue, Breast cancer, ATC, Embolism, Bleeding, VEGF, Weakness, Abdomen, Capecitabine, Pregnancy, Human, Safety, Gynaecology, NSCLC, Patient, Medical Subject Headings, Peritoneum, EGFR, Carboplatin, International, FIGO, Nutrient, Language, Blood, Cisplatin, Rectum, Oxygen, Anthracycline, Select, Ovary, Lung cancer, Allergy, Recurrence, European Medicines Agency, Growth, Doxorubicin, Taxane

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
RNA, Medical Subject Headings, Non-small-cell lung cancer, Marketing, Malignancy, European Commission, Agency, INN, Risk, Histology, ATC, International, European, Lung cancer, Injection, Disease, Body surface area, Language, DNA, Cisplatin, Cancer, Asbestos, Inflammation, Folate, Enzyme, Select, Committee, Patient, Cell, Dehydration, Risk management, Anatomy, Medicine, IIA, CHMP, Generic drug

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Akero Therapeutics Announces First Patients Dosed in Efruxifermin Phase 3 SYNCHRONY Program

Retrieved on: 
Monday, December 18, 2023
NAFLD, Marketing, Histology, FDA, Injection, Liver injury, EFX, SAN, Cirrhosis, Therapy, Lipid, DSM-IV codes, Patient, Safety, Diabetes, Fibrosis

SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program. Two parallel, randomized, placebo-controlled trials have commenced: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic nonalcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis (NASH/MASH), and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed NASH/MASH or non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease (NAFLD/MASLD).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program.
  • “We are thrilled to have dosed the first patients in our Phase 3 program and are delighted with the current level of engagement by clinicians and patients,” said Kitty Yale, chief development officer of Akero.
  • After 52 weeks, patients will continue treatment as randomized in SYNCHRONY Histology to be followed for long-term clinical outcomes, such as progression to cirrhosis.
  • SYNCHRONY Real-World is expected to enroll approximately 600 patients with NASH/MASH or NAFLD/MASLD diagnosed by non-invasive tests to receive weekly injections of EFX 50mg or placebo.

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

Retrieved on: 
Monday, December 18, 2023
Patient, Immunotherapy, NGS, Neoplasm, PR, CDKN2B, CDK2, Histology, Glioma, DLT, CYCC, Lung, CDK9, PLK1, Metformin, Half-life, Melanoma, Hyperglycemia, Blood, Cyclacel, Cancer, Endometrial cancer, T-cell lymphoma, Mesothelioma, Head, Laboratory, Pancreatic cancer, MTAP, Biomarker, Tablet, Lymphoma, NSCLC, Deletion, PRMT5, Neck

BERKELEY HEIGHTS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (“fadra”) in patients with advanced solid tumors and lymphoma.

Key Points: 
  • “The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies.
  • The Phase 2 part of 065-101 is designed to evaluate fadra safety and efficacy in cohorts defined by histology and/or next generation sequencing (NGS).
  • “After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with fadra, we found four patients with CDKN2A, CDKN2B and/or MTAP deletions.
  • CDKN2B deletions occur in over 30% of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl.

89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

Retrieved on: 
Monday, December 4, 2023
Patient, Liver, NASH, Histology, FDA, EMA, SAN, Cirrhosis, Safety, Fibrosis, Pharmaceutical industry

SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH. The program will include two Phase 3 trials evaluating patients with NASH: ENLIGHTEN-Cirrhosis will enroll patients with compensated cirrhosis (F4) and ENLIGHTEN-Fibrosis will enroll patients with fibrosis stage F2-F3. The F2-F3 and the F4 trials are expected to initiate in the first quarter and the second quarter of 2024, respectively. Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.

Key Points: 
  • The F2-F3 and the F4 trials are expected to initiate in the first quarter and the second quarter of 2024, respectively.
  • Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.
  • ENLIGHTEN-Cirrhosis, in patients with compensated F4 NASH: The trial will evaluate the efficacy and safety of pegozafermin administered 30mg weekly.
  • Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.

The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition - COVID-19 Impact, Regions of Market Influence and What to Watch For Long-Term - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 27, 2023
Infectious Diseases, Biotechnology, Health, COVID-19, Infection, Histology, Government, Research, Market, Test management, Size, Projection, Point, Point of care, Blood bank, IVD, Medical device

The "Worldwide Market for In Vitro Diagnostic Tests, 16th Edition" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Worldwide Market for In Vitro Diagnostic Tests, 16th Edition" report has been added to ResearchAndMarkets.com's offering.
  • The 16th edition of The Worldwide Market for In Vitro Diagnostic Tests is based on vendor reporting, interviews, vendor activities, and more on a global scale.
  • The 16th edition of the Worldwide Market for In Vitro Diagnostic Tests is a must have for anyone interested or involved in the IVD industry.
  • The 16th edition of the Worldwide Market for In Vitro Diagnostic Tests provides readers with reliable estimates, real-world forecasts, and insights needed to understand the IVD market in its entirety.